Spinal implant and method of manufacture

ABSTRACT

A bone fastener includes a screw shaft having a proximal portion and a distal portion. The proximal portion is formed by a first manufacturing method and defines a distal face. The distal portion is formed onto the distal face by a second manufacturing method. In some embodiments, systems, spinal constructs, surgical instruments and methods are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of spinal disorders, and more particularly to a spinal implantsystem having spinal implants manufactured by a method including aplurality of manufacturing techniques.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs including bone fasteners are often used to provide stabilityto a treated region. Such bone fasteners are traditionally manufacturedusing a medical machining technique. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a bone fastener is provided. The bone fastenerincludes a screw shaft having a proximal portion and a distal portion.The proximal portion is formed by a first manufacturing method anddefines a distal face. The distal portion is formed onto the distal faceby a second manufacturing method. In some embodiments, systems, spinalconstructs, spinal implants, surgical instruments and methods aredisclosed.

In one embodiment, a method for fabricating a bone fastener is provided.The method comprises the steps of: forming a proximal portion of a screwshaft of a bone fastener by a first manufacturing method, the proximalportion defining a distal face; generating a digital representation of aconfiguration of a distal portion of the screw shaft; storing thedigital representation on a database coupled to a processor; and formingthe distal portion by a second manufacturing method that includes anadditive manufacturing method such that the processor instructs anadditive manufacturing apparatus to form the distal portion onto thedistal face.

In one embodiment, the bone fastener includes a head. A threaded shaftincludes a proximal portion and a distal portion. The proximal portionis formed by a subtractive, deformative or transformative manufacturingmethod to include a first thread form and define a distal face. Thedistal portion is formed onto the distal face in a layer by layerformation by an additive manufacturing method. The distal portionincludes a second thread form.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 2 is a side view of components of the system shown in FIG. 1 ;

FIG. 3 is a side view of components of the system shown in FIG. 1 ;

FIG. 4 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 5 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 6 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 7 is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 8 is a flow diagram illustrating representative steps for producingcomponents of one embodiment of a system in accordance with theprinciples of the present disclosure;

FIG. 9 is a perspective view of components of one embodiment of a systemin accordance with the principles of the present disclosure;

FIG. 10 is a perspective view of components of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 11 is a side view, in part cross section, of components of oneembodiment of a system in accordance with the principles of the presentdisclosure;

FIG. 12 is a side view, in part cross section, of components of oneembodiment of a system in accordance with the principles of the presentdisclosure;

FIG. 13 is a side view, in part cross section, of components of oneembodiment of a system in accordance with the principles of the presentdisclosure;

FIG. 14 is a side view, in part cross section, of components of oneembodiment of a system in accordance with the principles of the presentdisclosure;

FIG. 15 is a side view, in part cross section, of components of oneembodiment of a system in accordance with the principles of the presentdisclosure;

FIG. 16 is a side, cross section view of components of one embodiment ofa system in accordance with the principles of the present disclosure;

FIG. 17 is a side, cross section view of components of one embodiment ofa system in accordance with the principles of the present disclosure;and

FIG. 18 is a side, cross section view of components of one embodiment ofa system in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a spinal implant system having spinal implants manufactured by amethod including a plurality of manufacturing techniques. In someembodiments, the spinal implant system includes a spinal implantcomprising a bone screw including a hybrid medical device. In someembodiments, the spinal implant is manufactured via a traditionalmanufacturing technique and an additive manufacturing technique.

In some embodiments, the spinal implant system of the present disclosurecomprises a spinal implant, surgical instrument and/or medical devicehaving a hybrid configuration that combines a manufacturing method, suchas, for example, one or more traditional manufacturing features andmaterials and a manufacturing method, such as, for example, one or moreadditive manufacturing features and materials. In some embodiments,additive manufacturing includes 3-D printing. In some embodiments,additive manufacturing includes fused deposition modeling, selectivelaser sintering, direct metal laser sintering, selective laser melting,electron beam melting, layered object manufacturing andstereolithography. In some embodiments, additive manufacturing includesrapid prototyping, desktop manufacturing, direct manufacturing, directdigital manufacturing, digital fabrication, instant manufacturing andon-demand manufacturing.

In some embodiments, the spinal implant system of the present disclosurecomprises a spinal implant, such as, for example, a bone screwmanufactured by combining traditional manufacturing methods and additivemanufacturing methods. In some embodiments, the bone screw ismanufactured by applying additive manufacturing material in areas wherethe bone screw can benefit from materials and properties of additivemanufacturing. In some embodiments, traditional materials are utilizedwhere the benefits of these materials, such as physical properties andcost, are superior to those resulting from additive manufacturingfeatures and materials.

In some embodiments, the bone screw is manufactured by combiningtraditional manufacturing methods and additive manufacturing such that adistal end of the bone screw is manufactured by additive manufacturingwhile a proximal end is manufactured by traditional methods andmaterials, such as, for example, subtractive manufacturing. In someembodiments, the proximal end is manufactured by wrought or from othermaterials that have enhanced physical properties relative to additivematerials. In some embodiments, the distal end of the screw is subjectedto higher loads and the physical properties of traditional materialsoffer benefits in performance and cost when compared to additivematerials. In some embodiments, utilizing additive manufacturing tocreate the distal end of the bone screw can provide a bone in-growthsurface along with complex internal and external features.

In some embodiments, the surgical system of the present disclosurecomprises combining traditional manufacturing methods and materials withadditive manufacturing to fabricate a spinal implant, such as, forexample, a hybrid bone screw that facilitates bony fixation, ingrowthand purchase with tissue. In some embodiments, the hybrid bone screwprovides improvement in stability of the bone screw when the distal endis engaged with tissue. In some embodiments, the bone screw isdisposable with tissue in a cantilever configuration that supports aload on the hybrid bone screw in an even distribution. For example, aproximal portion of a bone screw fabricated from a traditionalmanufacturing method can include strength and stability features forsupporting a load, for example, connection with a spinal rod. A distalportion of the bone screw fabricated from an additive manufacturingmethod can include fixation, ingrowth and porosity features, forexample, to facilitate purchase with tissue. In some embodiments,applications of the present hybrid manufacturing technique employed forproducing surgical instruments allows additive features to be added to asurgical instrument such that the surgical instrument includes selectedfeatures and/or features with complex internal geometry.

In some embodiments, the proximal end is manufactured by a traditionalmanufacturing method that employs a lathe, Swiss lathe, mill turning,whirling, grinding and/or roll forming. In some embodiments, theproximal end is disposed with a part, such as, for example, a buildplate in connection with an additive forming technique. In someembodiments, the plate includes one or a plurality of openingsconfigured for disposal of the proximal end. In some embodiments, theopenings are threaded to facilitate connection of the proximal end withthe plate. In some embodiments, the threaded surface is utilized tocontrol thread orientation and timing of deposition and/or heating. Insome embodiments, the openings are selectively shaped to facilitateconnection with the proximal end. In some embodiments, the plateincludes cavities, such as, for example, pockets that are selectivelyshaped to facilitate connection with the proximal end. In someembodiments, a distal face of the proximal end is engaged with one ofthe openings such that the distal face is disposed in a flushorientation with a surface of the plate. In some embodiments, theproximal end is disposed perpendicular to the plate. In someembodiments, the proximal end may be disposed in various orientationsrelative to the plate.

In some embodiments, the method of manufacturing the distal end includesa step of connecting the proximal end with the plate. In someembodiments, the method of manufacturing the distal end includes thestep of providing a heat source to heat a powder deposited on the distalface of the proximal end. In some embodiments, the method ofmanufacturing the distal end includes the step of leveling the powder toa consistent thickness. In some embodiments, the method of manufacturingthe distal end includes the step of melting the powder. In someembodiments, the method of manufacturing the distal end includes thestep of translating the plate, such as, for example, in a downwarddirection to facilitate applying additional layers of the powder. Insome embodiments, the method of manufacturing includes the step ofdisengaging the bone screw, such as, for example, by unscrewing the bonescrew from the plate.

In some embodiments, the surgical system of the present disclosurecomprises a threaded pedicle screw including a porous portion forenhancing bony fixation, ingrowth and purchase when implanted in bone.In some embodiments, the porous portion is manufactured on a distalsurface of a proximal portion. In some embodiments, the porous portionis formed by 3-D printing. In some embodiments, the proximal portion ofthe bone screw is substantively manufactured and the distal portion isadditively manufactured. In some embodiments, the distal portion mayinclude needle-like protrusions and/or lattice structures, and/orprotruding/depressed features, whether regular or irregular. In someembodiments, the materials utilized to manufacture the bone screwinclude stainless steel, titanium, cobalt-chromium, polymers, silicone,biologics and/or tissue. In some embodiments, the bone screw can bemanufactured using wrought, forged, metal injection molded, roll formed,injection molded and/or machined materials, as described herein. In someembodiments, the distal portion is manufactured by additivemanufacturing and connected with the proximal portion. In someembodiments, the distal portion is manufactured by additivemanufacturing and mechanically attached with the proximal portion by,for example, welding, threading, adhesives and/or staking.

In some embodiments, the spinal implants, surgical instruments and/ormedical devices of the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the spinal implants, surgical instruments and/or medicaldevices of the present disclosure may be employed with other osteal andbone related applications, including those associated with diagnosticsand therapeutics. In some embodiments, the spinal implants, surgicalinstruments and/or medical devices of the present disclosure may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, lateral,postero-lateral, and/or antero-lateral approaches, and in other bodyregions such as maxillofacial and extremities. The spinal implants,surgical instruments and/or medical devices of the present disclosuremay also be alternatively employed with procedures for treating thelumbar, cervical, thoracic, sacral and pelvic regions of a spinalcolumn. The spinal implants, surgical instruments and/or medical devicesof the present disclosure may also be used on animals, bone models andother non-living substrates, such as, for example, in training, testingand demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a spinal implant, amethod of manufacturing a spinal implant, related components and methodsof employing the surgical system in accordance with the principles ofthe present disclosure. Alternate embodiments are disclosed. Referenceis made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-3 , there are illustrated components of a spinal implantsystem 10 including spinal implants, surgical instruments and medicaldevices.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyimide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 includes a spinal implant, such as, forexample, a bone fastener 12 that defines a longitudinal axis X1. Bonefastener 12 includes an elongated screw shaft 18 having a proximalportion 14 fabricated by a first manufacturing method and a distalportion 16 fabricated by a second manufacturing method to enhancefixation and/or facilitate bone growth, as described herein. In someembodiments, the manufacturing method can include a traditionalmachining method, such as, for example, subtractive, deformative ortransformative manufacturing methods. In some embodiments, thetraditional manufacturing method may include cutting, grinding, rolling,forming, molding, casting, forging, extruding, whirling, grinding and/orcold working. In some embodiments, the traditional manufacturing methodincludes portion 14 being formed by a medical machining process. In someembodiments, medical machining processes can include use of computernumerical control (CNC) high speed milling machines, Swiss machiningdevices, CNC turning with living tooling, wire EDM 4^(th) axis and/orSolid Works™ CAD, and Virtual Gibbs™ solid model rendering. In someembodiments, the manufacturing method for fabricating portion 14includes a finishing process, such as, for example, laser marking,tumble blasting, bead blasting, micro blasting and/or powder blasting.

For example, portion 14 is formed by a manufacturing method, whichincludes feeding a straightened wire W into a machine that cuts wire Wat a designated length to form a screw blank, as shown in FIG. 4 , anddie cuts a head of the screw blank into a selected configuration, asshown in FIG. 5 . Portion 14 is manufactured to include a head 20 and aportion of screw shaft 18. Portion 14 extends between an end 24 and anend 26. End 24 includes head 20.

Portion 14 includes threads 28, which are fabricated by traditionalmachining methods, as described herein. Threads 28 extend along all or aportion of portion 14. Threads 28 are oriented with portion 14 anddisposed for engagement with tissue. In some embodiments, threads 28include a fine, closely-spaced configuration and/or shallowconfiguration to facilitate and/or enhance engagement with tissue. Insome embodiments, threads 28 include a smaller pitch or more threadturns per axial distance to provide a stronger fixation with tissueand/or resist loosening from tissue. In some embodiments, threads 28include a greater pitch and an increased lead between thread turns. Insome embodiments, threads 28 are continuous along portion 14. In someembodiments, threads 28 are continuous along shaft 18 via a secondmanufacturing method, as described herein. In some embodiments, threads28 may be intermittent, staggered, discontinuous and/or may include asingle thread turn or a plurality of discrete threads. In someembodiments, other penetrating elements may be located on and/ormanufactured with portion 14, such as, for example, a nailconfiguration, barbs, expanding elements, raised elements, ribs, and/orspikes to facilitate engagement of portion 14 with tissue.

End 26 includes a surface 30 that defines a distal face 32. In someembodiments, surface 30 may be disposed along a length of portion 14 orat a distalmost surface of portion 14. In some embodiments, distal face32 extends perpendicular to axis X1, as shown in FIG. 6 . In someembodiments, distal face 32 may be disposed in various orientationsrelative to axis X1, such as, for example, transverse and/or at angularorientations, such as acute or obtuse. In one embodiment, as shown inFIG. 7 , distal face 32 is disposed at an acute angular orientationrelative to axis X1.

Distal face 32 is configured for providing a fabrication platform forforming portion 16 thereon with an additive manufacturing method, asdescribed herein. Distal face 32 has a substantially planarconfiguration for material deposition and/or heating during an additivemanufacturing process for fabricating portion 16 onto distal face 32. Insome embodiments, all or only a portion of distal face 32 may havealternate surface configurations, such as, for example, angled,irregular, uniform, non-uniform, offset, staggered, tapered, arcuate,undulating, mesh, porous, semi-porous, dimpled, pointed and/or textured.In some embodiments, distal face 32 may include a nail configuration,barbs, expanding elements, raised elements, ribs, and/or spikes toprovide a fabrication platform for forming portion 16 thereon with anadditive manufacturing method, as described herein. In some embodiments,all or only a portion of distal face 32 may have alternate cross sectionconfigurations, such as, for example, oval, oblong triangular, square,polygonal, irregular, uniform, non-uniform, offset, staggered, and/ortapered.

Portion 16 is fabricated with a second manufacturing method by disposinga material M onto distal face 32, as described herein. Portion 16 isconfigured for fabrication on distal face 32 such that portion 16 isfused with surface 30. Portion 16 is formed on distal face 32 by anadditive manufacturing method. In some embodiments, portion 16 isfabricated by depositing material M onto distal face 32 one layer at atime, as described herein.

In some embodiments, additive manufacturing includes 3-D printing, asdescribed herein. In some embodiments, additive manufacturing includesfused deposition modeling, selective laser sintering, direct metal lasersintering, selective laser melting, electron beam melting, layeredobject manufacturing and stereolithography. In some embodiments,additive manufacturing includes rapid prototyping, desktopmanufacturing, direct manufacturing, direct digital manufacturing,digital fabrication, instant manufacturing or on-demand manufacturing.In some embodiments, portion 16 is manufactured by additivemanufacturing, as described herein, and mechanically attached withsurface 30 by, for example, welding, threading, adhesives and/orstaking.

In one embodiment, as shown in FIG. 8 , one or more manufacturingmethods for fabricating distal portion 16, proximal portion 14 and/orother components of bone fastener 12 include imaging patient anatomywith imaging techniques, such as, for example, x-ray, fluoroscopy,computed tomography (CT), magnetic resonance imaging (MRI), surgicalnavigation, and/or acquirable 2-D or 3-D images of patient anatomy.Selected configuration parameters of distal portion 16, proximal portion14 and/or other components of bone fastener 12 are collected, calculatedand/or determined. Such configuration parameters can include one or moreof patient anatomy imaging, surgical treatment, historical patient data,statistical data, treatment algorithms, implant material, implantdimensions, porosity and/or manufacturing method. In some embodiments,the configuration parameters can include implant material and porosityof distal portion 16 determined based on patient anatomy and thesurgical treatment. In some embodiments, the implant material includes aselected porosity P of distal portion 16, as described herein. In someembodiments, the selected configuration parameters of distal portion 16,proximal portion 14 and/or other components of bone fastener 12 arepatient specific. In some embodiments, the selected configurationparameters of distal portion 16, proximal portion 14 and/or othercomponents of bone fastener 12 are based on generic or standardconfigurations and/or sizes and not patient specific. In someembodiments, the selected configuration parameters of distal portion 16,proximal portion 14 and/or other components of bone fastener 12 arebased on one or more configurations and/or sizes of components of a kitof spinal implant system 10 and not patient specific.

For example, based on one or more selected configuration parameters, asdescribed herein, a digital rendering and/or data of a selected distalportion 16, proximal portion 14 and/or other components of bone fastener12, which can include a 2-D or a 3-D digital model and/or image, iscollected, calculated and/or determined, and generated for display froma graphical user interface, as described herein, and/or storage on adatabase attached to a computer and a processor (not shown), asdescribed herein. In some embodiments, the computer provides the abilityto display, via a monitor, as well as save, digitally manipulate, orprint a hard copy of the digital rendering and/or data. In someembodiments, a selected distal portion 16, proximal portion 14 and/orother components of bone fastener 12 can be designed virtually in thecomputer with a CAD/CAM program, which is on a computer display. In someembodiments, the processor may execute codes stored in acomputer-readable memory medium to execute one or more instructions ofthe computer, for example, to transmit instructions to an additivemanufacturing device, such as, for example, a 3-D printer. In someembodiments, the database and/or computer-readable medium may includeRAM, ROM, EPROM, magnetic, optical, digital, electromagnetic, flashdrive and/or semiconductor technology. In some embodiments, theprocessor can instruct motors (not shown) that control movement androtation of spinal implant system 10 components, for example, a buildplate 200, distal face 32 and/or laser emitting devices, as describedherein.

In some embodiments, the components of spinal implant system 10 caninclude one or more computer systems. In some embodiments, thecomponents of spinal implant system 10 can include computers and/orservers of a network having a plurality of computers linked to eachother over the network, Wi-Fi, Internet, comprise computers connectedvia a cloud network or in a data drop box. In some embodiments, thegraphical user interface may include one or more display devices, forexample, CRT, LCD, PDAs, WebTV terminals, set-top boxes, cellularphones, screen phones, smart phones, iPhone, iPad, tablet, wired orwireless communication devices.

Portion 14 is fabricated with threads 28 by a first manufacturingmethod, as described herein. Portion 14 is connected with a part, suchas, for example, a build plate 200 in connection with an additiveforming process and a second manufacturing method for fabricating distalportion 16. Build plate 200 is selectively configured for fabricating aselectively configured distal portion 16, as described herein, anddisposed with a working chamber 220 of a powder bed additivemanufacturing apparatus 222, as shown in FIGS. 9 and 10 . An enclosure221 of apparatus 222 defines working chamber 220.

Apparatus 222 includes a heating device, such as, for example, a laserdevice 224 disposed with working chamber 220 that fuses material M,which includes a powder, as described herein, in a slice by slice, layerby layer formation of portion 16 onto distal face 32. In someembodiments, laser device 224 includes an interactive laser and opticssystem that produces a laser beam scanned over a layer of material Mpowder disposed on build plate 200 to selectively heat the powderaccording to instructions received from the computer and processor basedon the digital rendering and/or data of the selected configuration ofportion 16. Laser device 224 heats a thin layer of material M powder inaccordance with slice data based on the digital rendering and/or data tofabricate portion 16, layer by layer, via an additive manufacturingtechnique. See, for example, the additive and three dimensionalmanufacturing systems and methods described in U.S. Pat. No. 5,204,055and US Patent Application Publication No. 2014/0252685, the contents ofeach of these references being hereby incorporated by reference hereinin their respective entireties.

In some embodiments, apparatus 222 includes a radiation source thatmelts and solidifies material M disposed with distal face 32 into adesired three-dimensional shape based on the selected configurationparameters, as described herein. In some embodiments, the radiationsource includes laser device 224, which comprises a carbon dioxidelaser. In some embodiments, laser device 224 may include a beam of anywavelength of visible light or UV light. In some embodiments, apparatus222 emits alternative forms of radiation, such as, for example,microwave, ultrasound or radio frequency radiation. In some embodiments,laser device 224 is configured to be focused on a portion of distal face32 to sinter material M deposited thereon, as shown in FIG. 11 . In someembodiments, laser device 224 emits a beam having a diameter betweenabout 0.01 mm and about 0.8 mm. In some embodiments, the diameter of thebeam may be between about 0.1 mm and about 0.4 mm. In some embodiments,the diameter of the beam is adjustable to customize the intensity of thesintering.

Build plate 200 includes a surface 202 that defines one or a pluralityof openings 204. Each opening 204 is configured for disposal of proximalportion 14 to orient distal face 32 as a fabrication platform forforming portion 16 thereon with an additive manufacturing method, asdescribed herein. The portions of surface 202 that define openings 204are threaded with surface 30 to facilitate connection with portion 14.Portion 14 is threaded with openings 204, as shown in FIG. 12 . Distalface 32 is disposed with opening 204 in a flush orientation with surface202, as shown in FIG. 13 , to orient distal face 32 for selective lasermelting with a powder bed process by apparatus 222.

In some embodiments, openings 204 are oriented with plate 200 to controlthread orientation and timing of deposition and/or heating of material Mwith distal face 32 to fabricate portion 16 in accordance with selectedconfiguration parameters, as described herein. Surface 30 is threadedwith surface 202 and distal face 32 is disposed with opening 204 in aperpendicular orientation relative to surface 202 and axis X1, as shownin FIG. 6 . In some embodiments, distal face 32 may be disposed withopening 204 in various orientations relative to surface 202, such as,for example, transverse and/or at angular orientations, such as acute orobtuse. In one embodiment, as shown in FIG. 7 , surface 30 is threadedwith surface 202 and distal face 32 is disposed with opening 204 at anacute angular orientation relative to axis X1. In some embodiments,portion 14 may be disposed with opening 204 in alternate connectionconfigurations, such as, for example, friction fit, pressure fit,locking protrusion/recess, locking keyway and/or adhesive.

In some embodiments, surface 202 includes pockets (not shown) disposedadjacent openings 204 that are selectively shaped to form selectiveconfigurations of portion 16, as described herein. In some embodimentplate 200 may be substantially non-conductive. In some embodiments,plate 200 may be ceramic, glass or non-metallic. In some embodiments,plate 200 may be formed of an electrical insulating material that isoperable to prevent an external heat control mechanism from heatingplate 200 to a sintering temperature of material M that is utilized toform the layers.

Build plate 200 is mounted with a platform 226 of apparatus 222 suchthat build plate 200 can be moved relative to enclosure 221 in one ormore directions to generate distal portion 16 onto distal face 32, layerby layer, based on the digital rendering and/or data. In someembodiments, build plate 200 can be translated vertically, horizontallyor diagonally, rotated, pivoted, raised and/or lowered to generatedistal portion 16. In some embodiments, build plate 200 can be movedrelative to enclosure 221 slidably, continuously, incrementally,intermittently, automatically, manually, selectively and/or viacomputer/processor control. In some embodiments, apparatus 222 comprisesan additive manufacturing device that employs selective laser meltingwith a powder bed process to create 3D objects. See, for example, theLasertec 30 SLM additive manufacturing machine manufactured by DMG MORICo. Ltd. located at 2-35-16 Meieki, Nakamura-ku, Nagoya City 450-0002,Japan.

In some embodiments, apparatus 222 is connected with one or morecomputer systems, processors and databases, as described herein, toreceive commands and instructions for creating distal portion 16 ontodistal face 32 by selective laser melting with a powder bed process byapparatus 222. For example, the commands and instructions are based onthe one or more selected configuration parameters of a selected distalportion 16 generated for display from a graphical user interface and/orstored on a database, as described herein. In some embodiments,apparatus 222 and/or the one or more computer systems can include akeyboard to input commands and instructions. In some embodiments, theprocessor receives the instructions and directs apparatus 222 tofabricate portion 16 based on the received instructions.

Material M powder is introduced in working chamber 220. Apparatus 222includes a coating arm (not shown) that translates within workingchamber 220 to deposit layers of material M powder along a planarsurface 228 of plate 200. In some embodiments, the coating arm includesa blade that executes a displacement motion to sweep and/or depositmaterial M powder across distal face 32 and surface 228. In someembodiments, material M is introduced over the entire cross section ofworking chamber 220. Material M is leveled by the blade to a uniformand/or consistent thickness according to the selected configurationparameters, as described herein. In some embodiments, a powder bed isformed around portion 16 by excess powder accumulated during manufactureof each layer of portion 16. In some embodiments, the powder bed isconfigured as a support material during fabrication of portion 16 as thepart being constructed is surrounded by un-sintered powder at all times.In some embodiments, material M may include, such as, for example,stainless steel, titanium, cobalt-chromium, polymers, silicone,biologics and/or tissue. In some embodiments, a layer volume of materialM powder may be, such as, for example, 300×300×300 mm. In someembodiments, a cartridge-type supply/collection system for material M isprovided to facilitate powder delivery and recycling.

Laser device 224 focuses a laser beam to a layer M1 of material M powderdisposed with surface 228, as shown in FIG. 13 . Laser device 224 heats,melts and/or softens layer M1 to selectively heat material M powderaccording to instructions received from the computer and processor basedon the digital rendering and/or data of the selected configuration toproduce a layer of portion 16, as shown in FIG. 14 . Laser device 224articulates relative to plate 200 such that the supplied beam is focusedon the selected portions of material M deposited on distal face 32. Thebeam is focused onto portions of material M on distal face 32 to melt orsinter material M into a desired shape based on the selectedconfiguration parameters. Platform 226 moves plate 200 relative toenclosure 221, as described herein, for example, vertically downward totranslate portion 16 during fabrication of the successive layers ofportion 16 according to instructions received from the computer andprocessor.

After one layer of portion 16 is melted, plate 200 and the fabricatedlayer of portion 16 is translated vertically downward to align thefabricated layer such that the blade moves across surface 228 to sweepand/or deposit another layer M2 of material M powder across the priorfabricated layer on distal face 32 and plate 200 for melting, as shownin FIG. 14 . Layer M2 is leveled by the blade to a thickness accordingto the selected configuration parameters, as described herein. Laserdevice 224 heats, melts and/or softens layer M2 to selectively heatmaterial M powder to produce a successive layer of portion 16 accordingto instructions received from the computer and processor.

Portion 16 is built up layer by layer and the melting process isrepeated slice by slice, layer by layer, until the final layer ofmaterial M is melted and portion 16 is complete, as shown in FIG. 15 .Portion 16 is formed on distal face 32 to extend between an end 40 andend 42 according to instructions received from the computer andprocessor, and end 40 is fused with surface 30. End 42 includes a distaltip 44. In some embodiments, material M is subjected to direct metallaser sintering (DMLS®), selective laser sintering (SLS), fuseddeposition modeling (FDM), or fused filament fabrication (FFF), orstereolithography (SLA).

Portion 16 is fabricated according to instructions received from thecomputer and processor based on the digital rendering and/or data of theselected configuration, via the additive manufacturing process describedherein to include a thread 46 that extends between end 40 and distal tip44. Thread 46 is formed layer by layer by fabrication of portion 16, asdescribed herein. Thread 46 is fabricated to extend along all or aportion of portion 16. In some embodiments, thread 46 is fabricated toinclude a fine, closely-spaced and/or shallow configuration tofacilitate and/or enhance engagement with tissue. In some embodiments,thread 46 is fabricated to include a greater pitch and an increased leadbetween thread turns than thread 28, as shown in FIG. 1 . In someembodiments, thread 46 is fabricated to include a smaller pitch or morethread turns per axial distance than thread 28 to provide a strongerfixation with tissue and/or resist loosening from tissue. In someembodiments, thread 46 is fabricated to be continuous along portion 16.In some embodiments, thread 46 is fabricated to be continuous alongportion 16. In some embodiments, thread 46 is fabricated to beintermittent, staggered, discontinuous and/or may include a singlethread turn or a plurality of discrete threads. In some embodiments,portion 16 is fabricated to include penetrating elements, such as, forexample, a nail configuration, barbs, expanding elements, raisedelements, ribs, and/or spikes. In some embodiments, thread 46 isfabricated to be self-tapping or intermittent at distal tip 44. In someembodiments, distal tip 44 may be rounded. In some embodiments, distaltip 44 may be self-drilling.

Bone fastener 12 is disengaged from plate 200 upon fabrication ofportion 16 via an additive manufacturing method, as described herein.For example, portion 14 is removed from opening 204 of plate 200 suchthat surface 30 is unthreaded from surface 202. In some embodiments,portion 16 is subjected to a finishing process, such as, for example,laser marking, tumble blasting, bead blasting, micro blasting and/orpowder blasting. In some embodiments, the additive manufacturing methodmay include a 3-D printing head. In some embodiments, the additivemanufacturing method may include a temperature control unit such as, forexample, a heating or cooling unit to control a temperature of distalface 32. In some embodiments, the computer and processor provideinstructions for coordination of simultaneous and/or ordered movement ofplate 200, distal face 32, laser device 224, components of apparatus 222and/or introduction and layering of material M powder.

In some embodiments, portion 16 is fabricated in a configuration havinga porosity P via the additive manufacturing method, as described herein.In some embodiments, portion 16 is fabricated having a porosity P with aporogen that is spheroidal, cuboidal, rectangular, elongated, tubular,fibrous, disc-shaped, platelet-shaped, polygonal or a mixture thereof.In some embodiments, a porosity of portion 16 is based on a plurality ofmacropores, micropores, nanopores structures and/or a combinationthereof.

In some embodiments, the porogen is configured to diffuse, dissolve,and/or degrade after implantation into portion 16 leaving a pore. Theporogen may be a gas (e.g., carbon dioxide, nitrogen, argon or air),liquid (e.g., water, blood lymph, plasma, serum or marrow), or solid(e.g., crystalline salt, sugar). The porogen may be a water-solublechemical compound such as a carbohydrate (e.g., polydextrose, dextran),salt, polymer (e.g., polyvinyl pyrrolidone), protein (e.g., gelatin),pharmaceutical agent (e.g., antibiotics), or a small molecule. In otheraspects, the porous implant includes as a porogen polysaccharidescomprising cellulose, starch, amylose, dextran, poly(dextrose),glycogen, poly(vinylpyrollidone), pullulan, poly(glycolide),poly(lactide), and/or poly(lactide-co-glycolide). In other aspects, theuseful porogens include without limitations hydroxyapatite orpolyethylene oxide, polylactic acid, polycaprolactone. Peptides,proteins of fifty amino acids or less or a parathyroid hormone are alsouseful porogens.

In some embodiments, the porous configuration of portion 16 can exhibithigh degrees of porosity over a wide range of effective pore sizes. Insome embodiments, the porous configuration of portion 16 may have, atonce, macroporosity, mesoporosity, microporosity and nanoporosity.Macroporosity is characterized by pore diameters greater than about 100microns. Mesoporosity is characterized by pore diameters between about100 microns about 10 microns; and microporosity occurs when pores havediameters below about 10 microns. Microporous implants have pores ofdiameters below 9 microns, 8 microns, 7 microns, 6 microns, 5 microns, 4microns, 3 microns, 2 microns, and 1 micron. Nanoporosity of nanoporesis characterized by pore diameters of about 1 nm and below.

In some embodiments, portion 16 is fabricated with a material having aporosity P that is created by an additive manufacturing method, asdescribed herein, of a polymer material, for example, a polymer, onto abed of particles which are not soluble in the polymer and which can besubsequently leached by a non-solvent for the polymer. In this case, thepolymer which forms portion 16 is printed onto a bed of particles suchas salt, sugar, or polyethylene oxide. After the additive manufacturingmethod is complete, portion 16 is removed from the powder bed and placedin a non-solvent for the implant material which will dissolve theparticles. For example, polylactic acid in chloroform could be 3-Dprinted onto a bed of sugar particles, and the sugar can subsequently beleached with water.

In some embodiments, portion 16 is fabricated with a material having aporosity P that is created by an additive manufacturing method, asdescribed herein, by printing a solution containing an implant materialonto a heated bed of polymer. An example is 3-D printing polylactic acidin chloroform onto a bed of PLA particles heated to 100° C. The boilingpoint of chloroform is 60° C., and it will thus boil on hitting theparticle bed, causing a foam to form. This method of creating porosityis similar to 3-D printing a solution containing the implant materialonto a bed containing a foaming agent, which is another way of achievingporosity.

In some embodiments, bone fastener 12 includes an implant receiver (notshown) connectable with head 20. In some embodiments, bone fastener 12can include various configurations, such as, for example, a postedscrew, a pedicle screw, a bolt, a bone screw for a lateral plate, aninterbody screw, a uni-axial screw, a fixed angle screw, a multi-axialscrew, a side loading screw, a sagittal adjusting screw, a transversesagittal adjusting screw, an awl tip, a dual rod multi-axial screw,midline lumbar fusion screw and/or a sacral bone screw. In someembodiments, the implant receiver can be attached by manual engagementand/or non-instrumented assembly, which may include a practitioner,surgeon and/or medical staff grasping the implant receiver and shaft 18and forcibly snap or pop fitting the components together. In someembodiments, spinal implant system 10 comprises a kit including aplurality of bone fasteners 12 of varying configuration, as describedherein. In some embodiments, bone fastener 12 is selected from the kitand employed with a treatment at the surgical site.

In one embodiment, as shown in FIG. 16 , portion 16 is fabricated withan additive manufacturing method, as described herein, to define apassageway 302 such that portion 16 includes a cannulated configurationand a plurality of lateral fenestrations 304 in communication withpassageway 302. In some embodiments, portion 14 may be fabricated with atraditional manufacturing method, as described herein, to similarlydefine a portion of passageway 302 and fenestrations in communicationwith passageway 302. In one embodiment, as shown in FIGS. 17 and 18 ,portion 16 is fabricated with an additive manufacturing method, asdescribed herein, to include a mechanical lock, such as, for example, anexpanding barb 402 having rotatable arms 404 that pivot outwardly tofacilitate engagement with tissue.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-20. (canceled)
 21. A bone fastener comprising: a shaft including aproximal portion and a distal portion, the proximal portion having afirst porosity and defining a distal face, the distal portion having asecond porosity, different from the first porosity, the distal portionbeing formed onto the distal face.
 22. The bone fastener recited inclaim 21, wherein the second porosity is greater than the firstporosity.
 23. The bone fastener recited in claim 21, wherein theproximal portion is formed by a first manufacturing method to providethe first porosity and the distal portion is formed by a secondmanufacturing method to provide the second porosity, different from thefirst manufacturing method.
 24. The bone fastener recited in claim 21,wherein the second porosity is based on a plurality of macropores. 25.The bone fastener recited in claim 21, wherein the second porosity isbased on a plurality of micropores.
 26. The bone fastener recited inclaim 21, wherein the second porosity is based on a plurality ofnanopores structures.
 27. The bone fastener recited in claim 21, whereinthe second porosity is based on a combination of macropores, microporesand nanopores structures.
 28. The bone fastener recited in claim 21,wherein the second porosity has microporosity characterized by porediameters greater than about 100 microns.
 29. The bone fastener recitedin claim 21, wherein the second porosity has mesoporosity characterizedby pore diameters between about 100 microns about 10 microns.
 30. Thebone fastener recited in claim 21, wherein the second porosity hasmicroporosity characterized by pore diameters below about 10 microns.31. The bone fastener recited in claim 21, wherein the second porosityhas microporosity characterized by pore diameters below 1 micron. 32.The bone fastener recited in claim 21, wherein the second porosity hasnanoporosity characterized by pore diameters of about 1 nanometer andbelow.
 33. The bone fastener recited in claim 21, wherein the secondporosity has at once macroporosity, mesoporosity, microporosity andnanoporosity.
 34. The bone fastener recited in claim 21, wherein theproximal portion is formed from a first material and the distal portionis formed from a second material, different from the first material. 35.The bone fastener recited in claim 21, wherein the proximal portionincludes a first thread having a first pitch and the distal portionincludes a second thread having a second pitch, different from the firstpitch.
 36. The bone fastener recited in claim 35, wherein the secondthread is continuous with the first thread.
 37. The bone fastenerrecited in claim 21, wherein the proximal portion includes a head and ashaft extending from the head, the head including a planar proximalsurface and an arcuate side surface extending from the proximal surfaceto the shaft.
 38. The bone fastener recited in claim 21, wherein thehead includes a plurality of concentric ridges extending into the sidesurface.
 39. A bone fastener comprising: a shaft including a proximalportion and a distal portion, the proximal portion having a firstporosity and defining a distal face, the distal portion having a secondporosity, different from the first porosity, the distal portion beingformed onto the distal face, wherein the second porosity has at oncemacroporosity, mesoporosity, microporosity and nanoporosity, whereinmicroporosity is characterized by pore diameters greater than about 100microns, wherein mesoporosity is characterized by pore diameters betweenabout 100 microns about 10 microns, wherein microporosity ischaracterized by pore diameters below about 10 microns, and whereinnanoporosity is characterized by pore diameters of about 1 nanometer andbelow.
 40. A bone fastener comprising: a shaft including a proximalportion and a distal portion, the proximal portion having a firstporosity and defining a distal face, the distal portion having a secondporosity, different from the first porosity, the distal portion beingformed onto the distal face, wherein the proximal portion includes afirst thread having a first pitch and the distal portion includes asecond thread having a second pitch, different from the first pitch,wherein the second thread is continuous with the first thread, whereinthe proximal portion includes a head and a shaft extending from thehead, the head including a planar proximal surface and an arcuate sidesurface extending from the proximal surface to the shaft, and whereinthe head includes a plurality of concentric ridges extending into theside surface.